Follicular Lymphoma
Conditions
Brief summary
This study aims to evaluate how well the effectiveness of the medicine Tazemetostat works in adults with relapsed/refractory follicular lymphoma, a slow-growing type of blood cancer that affects a kind of white blood cell called lymphocytes. All participants will receive Tazemetostat as prescribed by their doctor in the routine clinical practice. The study will observe how participants respond to the treatment, how long the response lasts, and monitor safety, side effects and how well participants tolerate the treatment.
Detailed description
The results will be analyzed based on whether or not participants have a mutation in the Enhancer of zeste homolog 2 (EZH2) gene (known as EZH2 wild-type).
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adults aged 18 years or older * Histologically confirmed follicular lymphoma grades 1, 2, or 3A * At least two prior lines of systemic therapy * Prescribed tazemetostat according to United States prescribing information (USPI) * Known or planned EZH2 mutation status * Signed informed consent
Exclusion criteria
* Grade 3B or transformed follicular lymphoma * Other hematologic malignancies * Use of strong/moderate Cytochrome P450 (CYP3A) inhibitors * Pregnant or breastfeeding * Participation in another investigational program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Objective Response Rate (rwORR) stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | rwORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed by the investigator using the Lugano 2014 classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Best Overall Response (rwBOR) stratified by EZH2 mutation status. | From first dose to end of study participation, which may range from 1 day to up to 5 years. | rwBOR is defined as the best response assessed by the investigator using Lugano 2014 classification recorded from the start of treatment until disease progression or recurrence |
| Real-world Duration of Response (rwDOR) stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | rwDOR is defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause. |
| Real-world Progression-Free Survival (rwPFS) stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | rwPFS is defined as the time from the start of treatment to the date of first documented disease progression or death from any cause. |
| Real-world Disease Control Rate (rwDCR) stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | rwDCR is defined as the percentage of participants with CR, PR, or stable disease (SD) as their best response. |
| Percentage of participants starting at each initial dose level stratified by EZH2 mutation status. | At Day 1 | — |
| Percentage of participants with dose reductions and reasons for reduction stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | — |
| Duration of treatment (in days/months) stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | — |
| Percentage of participants with treatment interruptions and associated reasons stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | — |
| Percentage of participants with treatment discontinuation and associated reasons stratified by EZH2 mutation status. | Fom first dose to end of study participation, which may range from 1 day to up to 5 years. | — |
| Percentage of participants receiving subsequent systemic therapy after Tazemetostat stratified by EZH2 mutation status. | Fom last dose to end of study participation (up to 5 years). | — |
| Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs), including Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) | From first dose until 30 days after last dose. | An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is an AE for which the start date is on or after the date that the intervention began, or it was present prior to receiving the intervention but the intensity increased during the active phase of the study. |
Contacts
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed